No categories for this tab

About Us

About PharmaCountry
How It Works
Partnerships
Sustainability
Contact Us

For Buyers

Search Products
Search Services
Find Suppliers
Find Jobs
Find Seekers
Help Center
FAQ
Buyer Protection

For Sellers/Service Providers

Start Selling
Seller Guide
Pricing Plans
Advertising
Seller Support

Top Categories

Active Pharmaceutical Ingredients (APIs)
Finished Dosage Forms
Manufacturing Equipment & Utilities
Excipients & Additives
View All Categories

Stay Connected

[email protected]

24/7 Customer Support

Trusted B2B Platform

SSL Secure Transactions Verified Suppliers Quality Assured B2B Certified Global Network

© 2026 PharmaCountry. All rights reserved.

Privacy Policy Terms of Service Cookie Policy

Regulatory Updates | Pharmacountry Insights

Home/Insights/Regulatory Updates

Regulatory Updates

FDA, EMA, TGA and global regulatory developments

#regulatory submission ×

Daily News Market Analysis Research & Reports Regulatory Updates

Regulatory Updates

Sep 18, 2026•3 min read

Lupin Ltd Submits Original ANDA216716 to FDA – Tentative Approval

Lupin Ltd filed an original ANDA (application number ANDA216716) with the FDA, currently listed as Tentative Approval as of August 13, 2024.